Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease.

BACKGROUND: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. METHODS: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. RESULTS: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. CONCLUSIONS: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery.

OBJECTIVE: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. METHODS: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. RESULTS: Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. CONCLUSIONS: This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

A Quantitative Analysis of Publication Trends in Vascular Surgery and a Comparative Analysis with Interventional Radiology.

BACKGROUND: Since its recognition as an independent surgical subspecialty, vascular surgery has experienced rapid growth in both surgical volume and research productivity. Trends in vascular surgery research have not been well characterized. Understanding how research in the field has evolved in comparison to interventional radiology can offer insights into evolving interests and discrepancies between the specialties. METHODS: Primary and secondary research publications indexed in the MEDLINE database from 1992 to 2023 were analyzed using a novel text mining algorithm. Eight high-impact vascular surgery journals and 6 interventional radiology journals were included. Articles were categorized based on treatment modalities, pathologies, and other subgroup analyses. Temporal trends were assessed using linear regression and correlation analysis. A comparative analysis was performed assessing publication trends by broad pathology groups between vascular surgery and interventional radiology journals. A further subgroup analysis was conducted comparing publication trends by endovascular treatment modality for peripheral arterial disease (PAD). RESULTS: 28,931 vascular surgery publications and 13,094 interventional radiology publications met the inclusion criteria. Publication volume grew exponentially, with over 50% emerging in the last decade. Publications exploring endovascular interventions have increasingly exceeded those focused on exclusively open interventions in research volume since 2006. Aortic pathology, carotid disease, PAD, and venous pathology represented the vast majority of vascular surgery research output, with PAD exhibiting the fastest growth. Comparative analysis revealed a number of key differences in research focus and treatment modalities between vascular surgery and interventional radiology, including a greater emphasis on venous pathology in interventional radiology journals and fewer relative publications on carotid artery pathology (P < 0.001). When comparing endovascular treatments for PAD, interventional radiology journals published more frequently on endovascular brachytherapy (8.73% vs 1.02%, P < 0.001) and less frequently on atherectomy (4.29% vs 6.50%, P = 0.035) as compared to the vascular surgery journals. CONCLUSIONS: Our findings demonstrate increasing emphasis on endovascular interventions and specific pathologies in vascular surgery research. Despite some key differences, there is notable overlap in interests between vascular surgery and interventional radiology, which may represent promising opportunities for collaboration in advancing endovascular procedures. Differences in research focus may stem from specialty perspectives and be perpetuated by differences in training.

Preoperative thrombolysis is associated with improved vein patency and functional outcomes after first rib resection in acute Paget-Schroetter syndrome.

INTRODUCTION: Most patients with acute Paget-Schroetter syndrome (PSS) present in one of two manners: (1) thrombosis managed initially with thrombolysis and anticoagulation and then referred for surgery, and (2) initial treatment with anticoagulation only and later referral for surgery. Definitive benefits of thrombolysis in the acute period (the first 2 weeks after thrombosis) over anticoagulation alone have not been well reported. Our goal was to compare patients managed with early thrombolysis and anticoagulation followed by first rib resection (FRR) and later postoperative venography with venoplasty (PTA) with those managed with anticoagulation alone followed by FRR and PTA using vein patency assessed with venography and standardized outcome measures. METHODS: We reviewed a prospectively collected database from 2000 to 2019. Two groups were compared: those managed with early thrombolysis at our institution (Lysis) and those managed with anticoagulation alone (NoLysis). All patients underwent FRR. Venography was routinely performed before and after FRR. Standardized outcome measures included Quick Disability of Arm, Shoulder, and Hand (QuickDASH) scores and Somatic Pain Scale. RESULTS: A total of 50 Lysis and 50 NoLysis patients were identified. Pre-FRR venography showed that thrombolysis resulted in patency of 98% of veins, whereas 78% of NoLysis veins were patent. After FRR, postoperative venography revealed that 46 (92%) patients in the Lysis group and 37 (74%) patients in the NoLysis group achieved vein patency. Thrombolysis was significantly associated with final vein patency (odds ratio: 17 [4-199]; P < .001). Lysis patients had a trend toward lower QuickDASH scores from pre-FRR to post-FRR compared with NoLysis patients with a mean difference of -16.4 (±19.7) vs -5.2 (±15.6) points (P = .13). The difference in reduction of Somatic Pain Scale scores was not statistically significant. CONCLUSIONS: Thrombolysis as initial management of PSS, combined with anticoagulation, followed by FFR and VenoPTA resulted in improved final vein patency and may lead to an improved functional outcome measured with QuickDASH scores. Therefore, clinical protocols using thrombolysis as initial management should be considered when planning the optimal treatment strategy for patients with acute PSS.

Midterm Results of the Supera Stent for the Treatment of Femoropopliteal Occlusive Disease.

BACKGROUND: The Supera (Abbott Vascular, Santa Clara, CA) stent is an interwoven nitinol, shape-memory stent with high strength and flexibility characteristics which are purported to increase resistance to kinking and compression. The purpose of this study was to review single-center outcomes of the use of this stent in the femoropopliteal segment. METHODS: We performed a single-center, retrospective analysis of patients who underwent Supera stent placement for femoropopliteal occlusive disease from 2016-2019. Data was collected on patient demographics and procedural details. Follow-up imaging data, including duplex imaging and ankle-brachial indices, and clinical data were abstracted from encounter notes. RESULTS: Sixty-two patients with 72 unique Supera stent placements were identified. Mean age was 76 and 69% were male. 56% of patients had severe calcification and 11% had moderate calcification. 48% of lesions were Trans-Atlantic Inter-Society Consensus Document C or D lesions. Primary patency rates at 12, 24, and 36 months were 85%, 82%, and 75%, respectively. Primary patency was not affected significantly by lesion length, degree of calcification, number of outflow vessels, concomitant interventions, or stent size. CONCLUSIONS: These results demonstrate sustained primary patency with the Supera stent over a 3-year interval in treatment of patients with femoropopliteal occlusive disease, including in the setting of severely calcified vessels.

Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study.

BACKGROUND: Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation. OBJECTIVES: Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD. METHODS: REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events. RESULTS: A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1 cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6 cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR rate was 92.6% (87/94). No device or procedure related deaths and one index-limb major amputation were reported. CONCLUSIONS: Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.

Multidisciplinary Care for Critical Limb Ischemia: Current Gaps and Opportunities for Improvement.

Critical limb ischemia (CLI), defined as ischemic rest pain or nonhealing ulceration due to arterial insufficiency, represents the most severe and limb-threatening manifestation of peripheral artery disease. A major challenge in the optimal treatment of CLI is that multiple specialties participate in the care of this complex patient population. As a result, the care of patients with CLI is often fragmented, and multidisciplinary societal guidelines have not focused specifically on the care of patients with CLI. Furthermore, multidisciplinary care has the potential to improve patient outcomes, as no single medical specialty addresses all the facets of care necessary to reduce cardiovascular and limb-related morbidity in this complex patient population. This review identifies current gaps in the multidisciplinary care of patients with CLI, with a goal toward increasing disease recognition and timely referral, defining important components of CLI treatment teams, establishing options for revascularization strategies, and identifying best practices for wound care post-revascularization.

High resolution, 3-dimensional Ferumoxytol-enhanced cardiovascular magnetic resonance venography in central venous occlusion.

BACKGROUND: Although cardiovascular magnetic resonance venography (CMRV) is generally regarded as the technique of choice for imaging the central veins, conventional CMRV is not ideal. Gadolinium-based contrast agents (GBCA) are less suited to steady state venous imaging than to first pass arterial imaging and they may be contraindicated in patients with renal impairment where evaluation of venous anatomy is frequently required. We aim to evaluate the diagnostic performance of 3-dimensional (3D) ferumoxytol-enhanced CMRV (FE-CMRV) for suspected central venous occlusion in patients with renal failure and to assess its clinical impact on patient management. METHODS: In this IRB-approved and HIPAA-compliant study, 52 consecutive adult patients (47 years, IQR 32-61; 29 male) with renal impairment and suspected venous occlusion underwent FE-CMRV, following infusion of ferumoxytol. Breath-held, high resolution, 3D steady state FE-CMRV was performed through the chest, abdomen and pelvis. Two blinded reviewers independently scored twenty-one named venous segments for quality and patency. Correlative catheter venography in 14 patients was used as the reference standard for diagnostic accuracy. Retrospective chart review was conducted to determine clinical impact of FE-CMRV. Interobserver agreement was determined using Gwet's AC1 statistic. RESULTS: All patients underwent technically successful FE-CMRV without any adverse events. 99.5% (1033/1038) of venous segments were of diagnostic quality (score ≥ 2/4) with very good interobserver agreement (AC1 = 0.91). Interobserver agreement for venous occlusion was also very good (AC1 = 0.93). The overall accuracy of FE-CMRV compared to catheter venography was perfect (100.0%). No additional imaging was required prior to a clinical management decision in any of the 52 patients. Twenty-four successful and uncomplicated venous interventions were carried out following pre-procedural vascular mapping with FE-CMRV. CONCLUSIONS: 3D FE-CMRV is a practical, accurate and robust technique for high-resolution mapping of central thoracic, abdominal and pelvic veins and can be used to inform image-guided therapy. It may play a pivotal role in the care of patients in whom conventional contrast agents may be contraindicated or ineffective.

Underutilization of Thrombolytic Therapy for Patients Diagnosed with Acute Deep Venous Thrombosis in the Outpatient Setting.

BACKGROUND: Catheter-directed thrombolysis (CDT) has been shown to be a safe and effective treatment for the management of acute iliofemoral deep venous thrombosis (DVT). The potential benefits of this therapy include more rapid resolution of symptoms and possible reduction in the long-term sequelae. Many patients diagnosed with DVT in the inpatient setting have contraindications to lytic therapy, but less is known regarding the suitability of thrombolysis for outpatients diagnosed with acute DVT. We sought to determine the proportion of patients who were candidates for thrombolytic therapy and referred to a vascular specialist for evaluation. METHODS: A manual search of an outpatient vascular laboratory associated with a tertiary medical center was performed to identify all patients referred for the purpose of ruling out DVT between January 2013 and December 2014. Vascular laboratory studies conducted for evaluation of venous insufficiency were excluded. The electronic medical records were reviewed to evaluate for contraindications for thrombolysis. RESULTS: Over a 2-year period, there were 689 referrals to the outpatient vascular laboratory for the evaluation of patients with suspected DVT. Of the 689 referrals, 47 (6.8%) were found to have acute DVT, and 66 (9%) were found to have chronic DVT. Of the 47 patients with acute DVT, 41 involved the lower extremities. Fifteen of the 41 patients (37%) with extensive acute iliofemoral DVT had no absolute or major contraindications for CDT. Of these 15 patients, only 33% were referred to a vascular specialist (4 to vascular surgery and 1 to IR). Two patients (13%) agreed to and underwent successful CDT. CONCLUSIONS: Although the majority of patients with acute lower extremity DVT diagnosed in the outpatient vascular laboratory were not candidates for thrombolysis, one-third of those who may have benefited from CDT were referred to a vascular specialist to discuss lytic therapy. Given the potential benefits of CDT, it is imperative that patients with acute iliofemoral or extensive femoral DVT be offered an evaluation by a vascular specialist to optimize outcomes after this diagnosis.

Direct Cervical Carotid Angioplasty with Flow Reversal: A Single-Center Report from the Roadster Trial.

BACKGROUND: Carotid stent and/or angioplasty (CAS) via the transfemoral route with distal protection carries twice the risk of stroke and/or death when compared with carotid endarterectomy (CEA) in multiple randomized trials. Potential causes for this include disadvantaged aortic arch anatomy and the need to traverse the lesion to place a distal protection device. This report describes the technique and our experience with direct CAS using flow reversal for embolic protection. METHODS: University of California at Los Angeles (UCLA) division of Vascular and Endovascular surgery was a participant in the multi-institutional Roadster Trial of high-risk patients. We are reporting on our experience with 8 patients who met high-risk criteria. Using a small supraclavicular cutdown, the Michi sheath from Silk Road Medical was inserted into the common carotid artery. This provides a working channel for internal CAS as well as a side port to reverse and divert blood flow to the femoral vein, for embolic protection. All patients qualified as medically high risk because of a combination of factors including advanced age, smoking history, hypertension, diabetes, coronary artery disease, or hostile neck anatomy. RESULTS: All 8 patients had 3 or more risk factors including age >75 years (6 of 8), smoking (6 of 8), hypertension (7 of 8), overt coronary artery disease (4 of 8), diabetes (2 of 8), and chronic obstructive pulmonary disease (1 of 8). All stenoses were in the 80-99% category, and all were asymptomatic. All patients tolerated temporary clamping with flow reversal with no electroencephalogram changes. There were no deaths, strokes, transient ischemic attacks, or myocardial infarctions. All patients were discharged on the first postoperative day. Follow-up ranged from 7 to 21 months. One patient developed in-stent restenosis (asymptomatic). CONCLUSIONS: Direct CAS with flow reversal appears to be a safe, less invasive alternative to CEA.

Current treatment of renal artery aneurysms may be too aggressive.

OBJECTIVE: Most studies recommend repair of renal artery aneurysms (RAAs) >2 cm in diameter in asymptomatic patients, but other studies have suggested that their natural history may be more benign. We hypothesized that rupture and death in patients with asymptomatic RAAs is low and that current recommendations for RAA treatment at 2 cm may be too aggressive. METHODS: Retrospective review of all RAAs treated at a tertiary care medical center from 2002 to 2012. RESULTS: Fifty-nine RAA were identified in 40 patients (mean age at diagnosis, 56 years; male:female ratio, 17:23); 31 were saccular, 8 were fusiform, and 5 were bilobed. Twenty-nine patients were asymptomatic; the remainder of patients presented with hematuria (n = 4), abdominal pain (n = 3), difficult-to-control hypertension (n = 3), or flank pain (n = 2). Aneurysm location included the main renal artery bifurcation (n = 35), main trunk (n = 7), primary branch (n = 6), pole artery (n = 6), and secondary branch (n = 1). Operative management of RAAs included vein patch (n = 6), prosthetic patch (n = 4), primary repair (n = 3), plication (n = 1), patch and implantation (n = 1), and ex vivo repair (n = 1). Eight asymptomatic RAAs were treated surgically (mean RAA diameter = 2.4 ± 0.1 cm, range, 2-3 cm), with the remaining 33 asymptomatic RAAs being managed conservatively (mean RAA diameter = 1.4 ± 0.1 cm, range, 0.6-2.6 cm). Mean hospital length of stay was 4 days, with no late postoperative complications and 0% mortality. Non-operated patients were followed for a mean of 36 ± 9 months, with no late acute complications and 0% mortality. Mean RAA growth rate of patients with multiple imaging studies was 0.60 ± 0.16 mm/y. CONCLUSIONS: The rate of aneurysm rupture and death in our untreated RAA patients is zero, the growth rate is 0.60 ± 0.16 mm/y, and there were no adverse outcomes in asymptomatic RAAs >2 cm that were observed. We may currently be too aggressive in treating asymptomatic RAAs.

Endovenous ablation with concomitant phlebectomy is a safe and effective method of treatment for symptomatic patients with axial reflux and large incompetent tributaries.

OBJECTIVE: To examine outcomes following 1000 consecutive endovenous radiofrequency ablation (RFA) closures of saphenous veins and 500 ambulatory phlebectomy procedures for chronic venous insufficiency. Based on the outcomes in this patient cohort, we aim to determine whether concomitant or staged phlebectomy is preferred and examine the rate and optimal treatment of complications using a dedicated treatment algorithm based on our classification system for level of closure following these procedures. METHODS: Between 2004 and 2012, patients with symptomatic superficial venous incompetence who underwent endovenous RFA of incompetent saphenous veins were identified as well as patients with concomitant or staged microphlebectomy. Demographics, risk factors, procedural success rate, concurrent procedures, complications, and symptom relief were recorded. RESULTS: One thousand radiofrequency ablations (95.5% great saphenous vein and accessory great saphenous veins, 4.5% small saphenous vein) were performed in the ambulatory setting (patients = 735, limbs = 916); 355 limbs with large (>3 mm) symptomatic incompetent tributaries underwent concomitant phlebectomy. Additionally, 145 limbs required phlebectomy at a later setting for persistent symptoms following saphenous RFA. Indications for treatment included lifestyle-limiting pain (94.8%), swelling (66%), lipodermatosclerosis (5.3%), ulceration (9.4%), and/or bleeding (1.4%). All patients (100%) underwent a follow-up ultrasound 24 to 72 hours following the procedure to assess for successful closure and to rule out deep venous thrombosis. The majority of patients (86.7%) had relief of their symptoms at a mean follow-up of 9 months. No patients developed postoperative deep venous thrombosis; however, saphenous closure extended partially into the common femoral vein wall in 18 patients (1.8%) and flush with the saphenofemoral junction in 47 (4.7%). One patient developed a pulmonary embolus despite a normal postoperative ultrasound. No other patients required hospital admission and no deaths occurred during the follow-up period. CONCLUSIONS: The majority of patients with symptomatic chronic venous insufficiency benefit from endovenous RFA of incompetent saphenous veins with comparable results to published surgical outcomes for endovenous closure. The great majority of patients with refluxing tributary veins greater than 3 mm in diameter required phlebectomy in addition to saphenous ablation. These patients may benefit from concomitant phlebectomy along with endovenous saphenous closure.

Management of endovenous heat-induced thrombus using a classification system and treatment algorithm following segmental thermal ablation of the small saphenous vein.

OBJECTIVE: We evaluated our experience with segmental radiofrequency ablation (RFA) of the small saphenous vein (SSV), a less common procedure than great saphenous vein ablation, and developed a classification system and algorithm for endovenous heat-induced thrombus (EHIT), based on modifications of our prior algorithm of EHIT following great saphenous ablation. METHODS: Endovenous ablation was performed on symptomatic patients with incompetent SSVs following a minimum of 3 months of compression therapy. Demographic data, risk factors, CEAP classification, procedure details, and follow-up data were recorded. A four-tier classification system and treatment algorithm was developed, based on EHIT proximity to the popliteal vein. RESULTS: Eighty limbs (in 76 patients) were treated with RFA of the SSV between January 2008 and August 2012. Duplex ultrasound was performed between 24 and 72 hours postprocedure in all patients. Ablation was successful in 98.7% (79/80) of procedures. Sixty-eight (85%) patients had level A closures (≥ 1 mm caudal to popliteal vein) and 10 patients (13%) had level B closures (flush with popliteal vein) and were observed. Two limbs (3%) had EHIT extending into the popliteal vein (level C) and were treated with outpatient low-molecular-weight heparin anticoagulation. Thrombus retracted to the level of the saphenopopliteal junction in both patients following a short course of anticoagulation. No patient developed an occlusive deep vein thrombosis (DVT) (level D). Mean follow-up period was 6.2 months; no patient had small saphenous recanalization, occlusive DVT, or pulmonary embolus. The presence or absence of the Giacomini vein was not predictive of level B and C closure. CONCLUSIONS: RFA of the SSV in symptomatic patients has a high success rate with a low risk of DVT. A classification system and treatment protocol based on the level of EHIT in relation to the saphenopopliteal junction is useful in managing patients. The approach to patients with thrombus flush with the popliteal vein or bulging has not been previously defined; our outcomes were excellent, using our treatment algorithm.

Endovascular management of nonmalignant iliocaval venous lesions.

BACKGROUND: Iliocaval venous lesions produce a spectrum of symptoms ranging from mild swelling to venous ulcerations. In this study we examine the management and outcomes of these patients at our center. METHODS: In this study we performed a retrospective analysis of patients with symptomatic iliocaval venous stenoses, occlusions, or venous compression syndromes, who were treated with endovascular intervention during the period 2006-2010. RESULTS: Of the 36 patients evaluated, mean age was 43.0 years; prior deep venous thrombosis (DVT), pulmonary embolism (PE), and hypercoaguable states were present in 55.5%, 25.0%, and 44.4%, respectively. Patients were stratified by the presence (group I, n = 22) or absence (group II, n = 14) of underlying May-Thurner (MT) syndrome. In group I, 11 patients had nonocclusive MT-related stenoses and 11 had acute DVT with underlying MT, causing pain/swelling (100%), venous claudication (66.7%), or CEAP class 3 (95%) or 6 (5%). Female preponderance was 2.1:1. Eighteen patients had successful intervention (angioplasty/stent with or without lysis), with clinical improvement in 94.4% and a decrease in CEAP score in 83.3%. All group II patients had chronic iliocaval occlusions causing: pain (100%); swelling (88.9%); venous claudication (44.4%); or CEAP class 3 (58%), 4 (25%), or 6 (8%). Recanalization was attempted in all patients and was successful in 71.4%. Successful recanalization was associated with clinical improvement in 88.9% and a decrease in CEAP score in 44.4%. Complications included 2 early reocclusions, 2 hematomas, and no cases of PE or death. Primary and secondary 1-year patency was 86% and 100% overall (mean follow-up 9.6 months). Primary 1-year patency for groups I and II was 87.5% and 83.3%, respectively. CONCLUSIONS: Percutaneous intervention for chronic iliocaval venous lesions is associated with excellent 1-year patency rates and a significant reduction in symptoms and decrease in CEAP score.

Is heparin reversal required for the safe performance of percutaneous endovascular aortic aneurysm repair?

BACKGROUND: Percutaneous endovascular aneurysm repair (PEVAR) can be performed with high technical success rates and low morbidity rates. Several peer-reviewed papers regarding PEVAR have routinely combined heparin reversal with protamine before sheath removal. The risks of protamine reversal are well documented and include cardiovascular collapse and anaphylaxis. The aim of this study is to review outcomes of patients who underwent PEVAR without heparin reversal. METHODS: All patients who underwent percutaneous femoral artery closure after PEVAR between 2009-2012 without heparin reversal were reviewed. Only patients who underwent placement of large-bore (12- to 24-French) sheaths were included. Patient demographics, comorbidities, operative details, and complications were reported. RESULTS: One hundred thirty-one common femoral arteries were repaired using the Preclose technique in 76 patients. Fifty-five patients underwent bilateral repair and 21 underwent unilateral repair. The mean age was 73.9±9.1 years. The mean heparin dose administered was 79±25.4 U/kg. The mean patient body mass index was 27.5±4.8 kg/m2. Ultrasound-guided arterial puncture was performed in all patients. Average operative times were 196.5±103.3 min, and the mean estimated blood loss was 277.6 mL. Four femoral arteries (3%) required open surgical repair after failed hemostasis with ProGlide closure (Abbott Vascular, Abbott Park, IL). Two patients required deployment of a third ProGlide device with successful closure. Two patients had small (<3 cm) groin hematomas that had resolved at the time of the postoperative computed tomography scan. No pseudoaneurysms or arteriovenous fistulas developed in our patient cohort. No early or late thrombotic complications were noted. One patient (1.3%) with a ruptured aneurysm died 48 hours after endovascular repair unrelated to femoral closure. CONCLUSIONS: PEVAR may be performed with low patient morbidity after therapeutic heparinization without heparin reversal. Femoral artery repair after the removal of large-diameter sheaths using the Preclose technique can be performed in this setting with minimal rates of early and late bleeding or thrombosis.

Evaluation of an Infrapopliteal Drug-Eluting Resorbable Scaffold: Design Methodology for the LIFE-BTK Randomized Controlled Trial.

Background: Critical limb-threatening ischemia (CLTI) is a severe condition characterized by rest pain and ischemic tissue loss that affects 5% to 10% of people with peripheral artery disease. In the United States, there are few Food and Drug Administration-approved devices for the primary treatment of arteries below-the-knee (BTK). Unfortunately, all suffer from high restenosis rates due to intimal hyperplasia, elastic recoil, and untreated dissection because of a lack of scaffolding. The Esprit BTK system is a resorbable, drug-eluting scaffold device with the potential to address an unmet need in people suffering from CLTI because of infrapopliteal atherosclerosis. The LIFE-BTK (pivotaL Investigation of saFety and Efficacy of drug-eluting resorbable scaffold treatment-Below The Knee) randomized controlled trial (RCT) is a prospectively designed premarket evaluation of the Esprit BTK drug-eluting resorbable scaffold used in the treatment of those patients. Methods: The LIFE-BTK trial enrolled 261 subjects with CLTI for the RCT and a further 7 subjects for a pharmacokinetic substudy. The objective of the RCT was to evaluate the safety and efficacy of the Esprit BTK scaffold compared to percutaneous transluminal angioplasty. The primary efficacy end point was a composite of limb salvage and primary patency at 12 months. The primary safety end point is freedom from major adverse limb events and peri-operative death at 6 months and 30 days, respectively. Clinical follow-up care is planned for 5 years. Conclusions: Novel devices must be tested in RCTs to evaluate their safety and efficacy compared to the standard of care if we are to improve outcomes for this challenging group of patients.

Results of a double-barrel technique with commercially available devices for hypogastric preservation during aortoilac endovascular abdominal aortic aneurysm repair.

OBJECTIVE: To assess technical feasibility and short-term outcome of a novel hypogastric preservation technique in patients with aortoiliac aneurysms using commercially available endografts without device modification. METHODS: Multi-institution review of prospectively acquired database of patients undergoing double-barrel endograft repair of aortoiliac aneurysms. RESULTS: Twenty-two patients underwent endovascular aneurysm repair for aortoiliac aneurysms from 2010 to 2011, with 23 double-barrel hypogastric preservation procedures successfully completed in 21 patients. The technique involved bifurcated main body placement followed by simultaneous deployment of parallel endograft limbs into the external iliac (ipsilateral approach) and hypogastric (contralateral femoral or brachial approach) arteries. Bilateral hypogastric branches were performed in two patients, and unilateral branches with and without contralateral coil embolization were performed in nine and ten patients, respectively. Procedural success rate was 96%, technical success rate (successful implantation with immediate aneurysm exclusion and no observed endoleak) was 88%, and access was fully-percutaneous in 86%. Two type III endoleaks between branch components were noted on completion angiograms, but both resolved spontaneously on follow-up imaging. One type Ib endoleak was noted on postoperative imaging (contralateral to hypogastric branch, repaired with limb extension), as were three type II endoleaks (14%) without sac expansion. Early (<2 weeks) limb occlusion (one external iliac, two hypogastric) occurred in two patients, though no subsequent occlusions have occurred (mean follow-up, 7.2 months; range, 1-20 months). Primary patency for external iliac and hypogastric limbs at 6 months was 95% and 88%, respectively. There were no deaths; complications included groin hematoma in 10% and acute renal insufficiency in 5%. Buttock claudication (n = 4) only occurred in patients who had ipsilateral coil embolization of hypogastric arteries (n = 9) for bilateral iliac aneurysms in which only unilateral hypogastric preservation was performed, resulting in rate of 44% in these patients. CONCLUSIONS: The double-barrel technique for hypogastric preservation is technically feasible across multiple interventionalists using commercially available endografts without device modification. These procedures are associated with minimal morbidity, acceptable short-term limb-patency rates, and reduced buttock claudication compared with those involving contralateral hypogastric embolization.

Success of endovenous saphenous and perforator ablation in patients with symptomatic venous insufficiency receiving long-term warfarin therapy.

BACKGROUND: Endovenous ablation of great (GSV) and short saphenous vein (SSV) reflux has become the initial procedure for most patients with symptomatic venous insufficiency, and perforator ablation is increasingly used to assist in healing venous ulceration. Many patients have comorbid conditions, which require long-term anticoagulation with warfarin; however, the impact of a long-term anticoagulation therapy on endovenous ablation procedures is not understood. This study aims to determine the effects of chronic anticoagulation on the outcomes of endovenous ablation procedures in patients with chronic venous insufficiency (CVI). METHODS: Consecutive patients undergoing endovenous ablation for to Clinical severity (CEAP) class 2 through 6 CVI between January 1, 2005 and May 1, 2011 were evaluated; 781 patients with chronic venous reflux underwent 1,180 endovenous ablation procedures. We identified 45 patients receiving long-term anticoagulation therapy who underwent 71 endovenous ablation procedures, including 37 GSVs, 12 SSVs, and 22 perforator vein procedures. All patients underwent wound examination and duplex ultrasonography within 48 to 72 hours. Outcomes evaluated included closure rate and postoperative complications. RESULTS: The mean age of the patients was 69.7 ± 13 years. Most patients treated presented with active venous ulceration (59% CEAP 6). Indications for anticoagulation included atrial fibrillation (n = 9, 20%), previous deep venous thrombosis (n = 16, 36%), hypercoagulable state (n = 9, 20%), prosthetic valve (n = 2, 4%), and others (n = 9, 20%). All patients receiving warfarin therapy (100%) underwent a postprocedure ultrasonography, which confirmed the successful closure of the GSVs and SSVs; successful initial perforator closure was achieved in 59% of patients (13/22). Repeat perforator ablation yielded a closure rate of 77%. Compared with a matched cohort group of 35 patients (61 perforators) undergoing perforator ablation without anticoagulation, treated during the same period, there was no significant difference in the rates of successful closure between the groups. No patients developed postoperative deep venous thrombosis or pulmonary embolus. No additional thrombotic complications were noted. Three patients (4.2%) developed a small hematoma after the procedure, which resolved with conservative treatment. No patients required postoperative hospital admission, and no postprocedure deaths occurred. CONCLUSIONS: Based on our protocol, patients with severe CVI who were receiving long-term warfarin therapy can be treated safely and effectively with endovenous radiofrequency ablation for incompetent GSVs, SSVs, and perforator veins. Long-term warfarin therapy did not have a significant effect on perforator closure rates compared with no anticoagulation.